The present invention relates to novel methods and articles of manufacture which are packages containing compositions useful for effecting contraception in the human female. More particularly, the invention is directed to achieving contraception by administering a sequential dose of estrogen and progestogen, which includes a peak dosage of progestogen at approximately the mid-point of the menstrual cycle.
A number of regimens for controlling ovulation and conception by administering hormones are known, and are available commercially. Some of these are based on consistent dosage, throughout the administration period, of either estrogen or progestogen or both. Others are directed to biphasic treatments whereby the amounts of either or both of these hormones are increased or decreased at some point during the cycle. Closest to the regimen of the present invention are those administration programs which involve both progestogen and estrogen, and vary the amounts of either or both hormones such that a three-phase program is maintained. Methods of contraception which fit this description are found in U.S. Pat. Nos. 3,795,734 to American Home Products; 4,066,757 to Ortho; 3,957,982 to Schering A. G.; and German Pat. No. 2,431,704 to Asche. Of the aforementioned patents, that closest to the present invention is the Schering patent which describes a peak dosage of estrogen at the middle of the administration interval.
The present invention is designed so as to minimize the side effect of breakthrough bleeding by optimizing the amount of progestogen administered at the mid-point of the cycle.
The present invention also provides a "rest period" wherein no hormones are administered. Further, by peaking the dose of progestogen rather than estrogen, the total estrogen needed to be administered is minimized.